Jetstream G3 System
Pathway Medical Technologies
FDA Clearance Information
The Jetstream G3 System was cleared through the FDA's 510(k) pathway on December 1, 2009. Manufactured by Pathway Medical Technologies, it is classified as a Class 2 medical device.
What It Is
FDA-Cleared Indications
- Removal of atherosclerotic plaque from peripheral arteries.
- Removal of thrombus from peripheral arteries.
- Treatment of peripheral arterial disease involving obstructive arterial lesions.
Clinical Applications
- Peripheral arterial atherectomy to debulk plaque before or during endovascular treatment.
- Mechanical removal and aspiration of thrombotic material from peripheral arteries.
- Treatment of obstructive lesions in lower-extremity peripheral arteries.
- Use in catheter-based peripheral vascular procedures when plaque or thrombus limits blood flow.
Practical Considerations
- The system uses catheter sizes intended for different peripheral vessel diameters; the appropriate size depends on the target artery and lesion.
- Operation requires the dedicated power console and compatible guidewire-based catheter technique.
- The rotating cutting tip should be advanced and activated according to the device instructions to reduce the risk of vessel injury, perforation, embolization or dissection.
- The FDA record identifies the device as a peripheral atherectomy catheter; it should not be assumed to be cleared for coronary, carotid, intracranial or other non-peripheral vessels.
- MRI safety depends on the specific catheter and whether any component remains in or near the patient. The device labeling and MRI conditions should be reviewed before scanning; an unused or removed catheter does not create an ongoing implant.
Related Literature
Linked Studies (18)
Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study.
The International journal of angiology : official publication of the International College of Angiology, Inc
RCT View Source →Insights From the FDA's MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →JETWING technique: Combination therapy of JETSTREAMⓇ and aggressive wire recanalization in calcified atheroma and dilatation technique for eccentric heavy calcified plaques using WINGMAN for insertion of protection wire.
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
View Source →Jetstream Atherectomy with Paclitaxel-Coated Balloons: Two-Year Outcome of the Prospective Randomized JET-RANGER Study.
Vascular health and risk management
RCT|prospective|retrospective|case Series|other View Source →Jetstream Atherectomy Followed by Paclitaxel-Coated Balloons versus Balloon Angioplasty Followed by Paclitaxel-Coated Balloons: Twelve-Month Exploratory Results of the Prospective Randomized JET-RANGER Study.
Vascular health and risk management
RCT|prospective View Source →Jetstream Rotational Atherectomy and Drug Coated Balloon Angioplasty with In Stent Re-stenosis and Occlusions. A Two Centre Study.
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
View Source →JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
RCT|prospective|retrospective|case Series|other View Source →Jetstream Atherectomy in Treating Femoropopliteal In-Stent Restenosis: Meta-Analysis of the JETSTREAM-ISR and JET-ISR Trials.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.
Annals of vascular surgery
Other View Source →Jetstream Atherectomy System treatment of femoropopliteal arteries: Results of the post-market JET Registry.
Cardiovascular revascularization medicine : including molecular interventions
RCT|prospective|retrospective|case Series|other View Source →JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions.
The International journal of angiology : official publication of the International College of Angiology, Inc
RCT|prospective|retrospective|case Series|other View Source →Successful management of lower extremity distal embolization following percutaneous atherectomy with the JetStream G3 device.
The Journal of invasive cardiology
RCT|prospective|retrospective|case Series|other View Source →Use and abuse of atherectomy: where should it be used?
Seminars in vascular surgery
RCT|prospective|retrospective|case Series|other View Source →A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System
View Source →Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
View Source →Frequently Asked Questions
What is the Jetstream G3 System used for?
The Jetstream G3 System is used for removing plaque and thrombus from peripheral arteries, particularly in patients with peripheral artery disease.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the Jetstream G3 System.
What are the FDA-cleared indications?
The device is indicated for removing arterial plaque and thrombus to restore blood flow in patients with peripheral artery disease.